SUNNYVALE, Calif., June 18, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the Company’s Chief Executive Officer, Peter Altman, issued the following letter to shareholders. Dear Fellow Shareholders, Upon completion of our recent capital raise, I am providing this update on our strategy, top priorities, and business development opportunities to ensure understanding and appreciation of what is ahead. This quarter, with Japan’s Pharmaceutical and Medical Device Agency’s (PMDA) support for potential approval of CardiAMP® Cell Therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF), the submission for approval is a top priority. This effort is synergistic with our other important programs. In Japan, we have the opportunity to help patients having few additional treatment options and build the business with our first in class CardiAMP autologous minimally invasive cardiac cell therapy for ischemic HFrEF. There are an estimated 300,000 patients in Japan with ischemic heart failure. We expect the initial approval by PMDA would focus on enabling treatment for a subgroup of 20,000 patients. This is a compelling business opportunity, as previous cardiac cell therapies in Japan for treatment of chronic ischemic heart failure have had reimbursement at $124,000 per procedure. The submission for approval planned for end of 2026 is a meaningful milestone that could be transformative for our business. Strategic partners are expected to view the completed submission as a sign that our product will be in the market soon. The work to be done to complete the submission is significant as it involves ensuring strict regulatory audit readiness for our CardiAMP Cell Therapy System product candidate. Japan is a trusted Reference Country and a Primary Member of MDSAP Approval in Japan enables expedited registration based on reference country approvals in other regions of the world. Countries in Southeast Asia, Latin America, and the Middle East often designate Japan as a trusted “Reference Country.” These countries will often bypass secondary clinical testing, lower their local evaluation timelines, and reduce registration fees for potential distribution partners. Japan is also a primary member of the Medical Device Single Audit Program (MDSAP), alongside the United States, Canada, Australia, and Brazil. When our manufacturing plant passes a single, comprehensive MDSAP audit satisfying Japan’s PMD Act requirements, that audit report is accepted by other participating nations, avoiding the need for multiple independent factory inspections. CardiAMP HF II Trial Enrollment in USA We are also driving to enroll the confirmatory CardiAMP HF II Trial in the United States, which the FDA has said may support Premarket Approval. Each of the four active study centers has patients in the queue and we are working to onboard additional centers. The physicians and nurses on the clinical research teams at our U.S. centers are greatly interested in travelling to Japan to train and support their colleagues when they are ready to begin CardiAMP cell therapy procedures. Physicians from Japan may also come to observe CardiAMP HF II clinical cases and train on the procedures in advance of potential future approval in Japan. Pipeline-in-a-Product: Local Delivery to the Heart Our cell therapy programs utilize our Helix Transendocardial Delivery Catheter (Helix™) and our Heart3D™ fusion imaging platform (Heart3D). This system addresses the single greatest bottleneck facing cardiac cell, gene, and protein regenerative medicine today: inefficient localized delivery. By pairing our tissue-engaging helical needle with our partnered Heart3D fusion imaging platform, we have a therapeutic-agnostic infrastructure capable of servicing over fifty biotherapeutic programs currently in development. A number of these programs are in Japan, and Japan PMDA has already advised BioCardia that other developers would be enabled to use Helix with the approval of CardiAMP cell therapy. Worldwide, we have active early discussions with eight gene and cell therapies today intended for cardiac indications. No other delivery platform is as advanced or has close to the clinical experience that Helix has. Pipeline-in-a-Product: Off the Shelf MSC Therapies Our allogeneic mesenchymal stem cell (MSC) therapy platform is targeted towards cardiac and pulmonary indications where we have two FDA approved Investigational New Drug Applications (INDs), with anti-inflammatory mechanisms of action having potential applications across multiple high-value indications. Our manufacturing of clinical grade cells and supportive intellectual property enables us to partner in multiple indications that can be independently developed and partnered for value creation with other pharmaceutical developers. Japan PMDA and FDA have approved mesenchymal stem cell therapies for graft versus host disease, although the approval in Japan came ten years before the approval in the USA. In addition to partnering on distribution of CardiAMP, any significant partnership for our secured pipeline assets would be transformative for our business. Financial Strategy and Capital Allocation BioCardia has always had a modest cash burn for a publicly traded company. The recent clean financing closed last week should enable us to complete the submission of CardiAMP HF to Japan PMDA, enroll in CardiAMP HF II, and continue discussions around our pipeline opportunities. We are looking forward to revised SEC regulations later this year that may enable easier access to capital for smaller reporting companies. Near-Term Milestones and Outlook We are entering a period of high-impact catalysts: Shonin Submission of CardiAMP Cell Therapy to Japan PMDA (Q4 2026)Continued CardiAMP Cell Therapy development in the USA with FDA engagementStrategic partnership / licensing progress in Helix/Heart3D for cell, gene, and protein delivery to the heartStrategic partnerships / licensing around our clinical allogeneic MSC platform We believe these milestones create a compelling opportunity for value creation, particularly considering public market precedents for companies with similar clinical profiles and regulatory positioning. Conclusion BioCardia is focused on potential near term regulatory approval for a significant unmet need in Japan, a mission that is synergistic with our other efforts. We are a focused, capital-efficient organization advancing therapeutic solutions to address enormous unmet need. We have differentiated platforms, significant protective intellectual property, multiple shots on goal, and a clear path to near-term value inflection. We remain deeply committed to advancing therapies for life-threatening and chronic conditions while delivering on our responsibility to our stockholders. We appreciate your continued support and look forward to updating you on our progress in the months ahead. Sincerely, Peter Altman, PhD, FAHA Chief Executive Officer, BioCardia Inc. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to filings and communications with Japan’s PMDA and the FDA, submission for and subsequent market clearance of the CardiAMP Cell Therapy, partnering opportunities, enrollment in our clinical trials and anticipated upcoming milestones. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

SUNNYVALE, Calif., June 05, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use. FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials. “Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options,” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “FDA recognizes this need and the strengths in our completed CardiAMP HF clinical data to be the first of two trials to support Premarket Approval.” About CardiAMP Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Japan Pharmaceutical and Medical Device Agency has indicated that the clinical results from three completed clinical trials for the treatment of ischemic heart failure likely provide sufficient evidence of safety and efficacy to support a successful submission for approval. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use.  About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Upcoming Catalysts in 2026: CardiAMP HF Manuscript PublishedCardiAMP HF Japan PMDA Submission Q4 2026 Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to submission for and subsequent market clearance of the CardiAMP Cell Therapy. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

– Positive CardiAMP CMI Trial open-label cohort results demonstrated opportunity for locally delivered cell therapy to enhance therapeutic options for patients with severely symptomatic refractory angina and validate continued clinical development – Novel therapeutic approach targets a critically important unmet medical need for patients who have debilitated quality-of-life and have exhausted all available treatment options SUNNYVALE, Calif., May 21, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. (NASDAQ: BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the oral presentation of the results of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial (CardiAMP CMI) preliminary open label cohort at EuroPCR, a leading interventional cardiovascular medicine conference held in Paris. The presentation was made by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health. Results presented by Dr. Raval, on behalf of the CardiAMP CMI Investigators, showed that the minimally invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events and patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through 2 years follow-up. Prior to treatment, all patients were on guideline-directed medical therapy (GDMT) and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment. Dr. Raval’s presentation is here: EuroPCR2026. “Chronic ischemic heart disease results in considerable limitations of daily life activities due to chest discomfort, shortness of breath, and related disabling symptoms despite optimal medical therapy,” said Carl Pepine, MD, MACC, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida at Gainesville. “A cell-based approach, added to this medical therapy, has potential to better manage these symptoms and improve the quality of life.”  “We are thankful for the physician scientists who contributed their great experience to this program as well as the patients who participated,” said Peter Altman, PhD, BioCardia President and CEO. “These results support this CardiAMP cell therapy approach which has potential to help patients suffering from refractory angina. To our knowledge, only cell therapy has had a positive impact on both exercise tolerance and angina episodes in these patients.” About Chronic Myocardial Ischemia with Refractory Angina Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1.8 million patients in the United States. Up to 15% of patients who have ischemia or angina and undergo cardiac catheterization are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients.  About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures.  CAUTION – Limited by United States law to investigational use.  About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies.  For more information visit https://www.biocardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements may include, among other things, statements relating to the continued development, ability to offset clinical costs utilizing Medicare reimbursement and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

SUNNYVALE, Calif., April 20, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported a positive outcome in its formal clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA). PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP® Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Good alignment was achieved in the meeting on the acceptability of the foreign clinical data that has been developed in the United States, the indications for use in patients, the approach for introduction of the therapy in Japan, and the need for continued post marketing studies in Japan. The Company will await the minutes from PMDA to provide detailed feedback and timeline for potential filing.   “We are thankful for PMDA’s engagement and for the unanimous support of the world class cardiologists from Japan and the United States attending the meeting,” said BioCardia Chief Executive Dr. Peter Altman. “We are on track to have the first minimally invasive biologic therapy in ischemic heart failure approved in Japan.” About CardiAMP Autologous Cell TherapyGranted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use.  About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies.  For more information visit www.biocardia.com. Forward Looking Statements:This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to submission for and subsequent market clearance of CardiAMP Cell Therapy by PMDA. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact:Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact:David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120